ASTM F2384-10(2016)

Standard Specification for Wrought Zirconium-2.5Niobium Alloy for Surgical Implant Applications (UNS R60901)

ABSTRACT
This specification covers the requirements fro wrought zirconium-2.5niobium alloy for use in surgical implant applications. The material shall be manufactured into bars or wires by multiple vacuum melting in arc furnaces, by electron beam melting, or by other melting processes conventionally used for reactive metals. The material shall be in the annealed condition, with the surface descaled or pickled, abrasively blasted, chemically milled, ground, machined, peeled, or polished. Heat and product analyses and tests for tensile strength, yield strength, and elongation shall be performed and shall conform to the requirements specified. In addition, the material shall have a microstructure consisting of a fine dispersion of the alpha and beta phases as a result of processing in the alpha plus beta field, with no coarse, elongated alpha platelets.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought zirconium-2.5niobium alloy to be used in the manufacture of surgical implants (1).2  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

General Information

• Status: Published
• Publication Date: 31-Mar-2016
• ICS: 77.120.99 - Other non-ferrous metals and their alloys
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Refers: ASTM E8/E8M-15 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 01-Feb-2015
• Refers: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Apr-2016
• Refers: ASTM E8/E8M-16 - Standard Test Methods for Tension Testing of Metallic Materials
• Effective Date: 15-Jul-2016
• Refers: ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
• Effective Date: 01-Mar-2017
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis
• Effective Date: 01-Apr-2016

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F2384 −10 (Reapproved 2016)
Standard Specification for
Wrought Zirconium-2.5Niobium Alloy for Surgical Implant
1
Applications (UNS R60901)
This standard is issued under the fixed designation F2384; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.1 This specification covers the chemical, mechanical, and
SI 10 American National Standard for Use of the Interna-
metallurgical requirements for wrought zirconium-2.5niobium
2 tional System of Units (SI): The Modern Metric System
alloy to be used in the manufacture of surgical implants (1).
4
2.2 ISO Standard:
1.2 The values stated in either SI units or inch-pound units
ISO 6892 Metallic Materials Tensile Testing at Ambient
are to be regarded separately as standard. The values stated in
Temperature
each system may not be exact equivalents; therefore, each
ISO 9001 Quality Management Systems—Requirements
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance 3. Terminology
with the standard.
3.1 Definitions of Terms Specific to This Standard:
3.1.1 annealed, adj—material that exhibits a recrystalized
2. Referenced Documents
grain structure.
3
2.1 ASTM Standards:
3.1.2 lot, n—the total number of mill products produced
B550/B550M Specification for Zirconium and Zirconium
from the same melt heat under the same conditions at essen-
Alloy Bar and Wire
tially the same time.
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
4. Product Classification
E29 Practice for Using Significant Digits in Test Data to
4.1 bar—rounds, flats or shapes from 4.76 to 101.60 mm
Determine Conformance with Specifications
[0.1875 to 4 in.] in diameter or thickness (other sizes and
E112 Test Methods for Determining Average Grain Size
shapes by special order).
E1552 Test Method for Determining Hafnium in Zirconium
4.2 wire—rounds or flats less than 4.76 mm [0.1875 in.] in
andZirconiumAlloysByDirectCurrentPlasma—Atomic
diameter or thickness.
Emission Spectrometry
E1941 Test Method for Determination of Carbon in Refrac-
5. Ordering Information
tory and Reactive Metals andTheirAlloys by Combustion
Analysis 5.1 Include with inquiries and orders for material under this
E2626 Guide for Spectrometric Analysis of Reactive and specification the following information:
Refractory Metals 5.1.1 Quantity,
F67 Specification for Unalloyed Titanium, for Surgical Im- 5.1.2 ASTM designation and date of issue,
plant Applications (UNS R50250, UNS R50400, UNS 5.1.3 Units to be certified—SI or inch-pound,
R50550, UNS R50700) 5.1.4 Grade (if applicable),
5.1.5 Form (bar, or wire),
5.1.6 Condition (see 6.3),
1
This specification is under the jurisdiction of ASTM Committee F04 on
5.1.7 Mechanical properties (if applicable for special
Medical and Surgical Materials and Devices and is the direct responsibility of
conditions),
Subcommittee F04.12 on Metallurgical Materials.
Current edition approved April 1, 2016. Published June 2016. Originally
5.1.8 Finish (see 6.2),
approved in 2005. Last previous edition approved in 2010 as F2384 – 10. DOI:
5.1.9 Applicabledimensionincludingsize,thickness,width,
10.1520/F2384-10R16.
or drawing number,
2
The boldface numbers in parentheses refer to the list of references at the end of
this standard. 5.1.10 Special tests, if any, and
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2384−10 (2016)
TABLE 2 Product Analysis Tolerances
5.1.11 Other requirements.
Permissible Variation from
Alloying Element the Specified Range,
6. Materials and Manufacture
% mass/mass
6.1 Materials covered by this specification shall be pro-
Niobium 0.050
duced by multiple vacuum melting in arc furnaces, electron
Oxygen 0.020
Carbon 0.002
beam melting, or other melting processes conventionally used
Chromium 0.002
for reactive metals.
Hafnium 0.002
Hydrogen 0.0005
6.2 Finish—The mill product may be furnished to the
I
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